REPORT 6The History of Medical Progress written by Dr. Ray Greek, Director of the Medical Research Modernization Committee

"If I, an internationally recognized scientist and consultant to heads of state and national academies, couldnot secure protection under federal law, how can U.S. citizens believe thatanyone, let alone younger, lesser-known scientists, dare to oppose scientificmisconduct, animal abuse and the misdeeds of corrupt administrations?"- Jan Moor-Jankowski, M.D.

ACTION is part of Agency's long-standing pattern of failure to uphold the law.

Ron Wood's crack-smoking experiments: A case study of waste, fraud and animal abuseA Report By In Defense of AnimalsSeptember 1996OverviewDr. Wood's crack-smoking experiments on monkeys were halted last year amidsta national scandal and federal charges for animal welfare violations. Theexperiments had previously been suspended pending the results of two federalinvestigations. After his grant from the National Institute on Drug Abuse(NIDA) expired in August 1995, Dr. Wood, according to an NYU spokesperson,took an "indefinite" leave of absence from NYU. Dr. Wood recentlyre-surfaced at the University of Rochester. Following a one-year hiatus,NIDA re-funded Dr. Wood's experiments to the tune of $420,000 per year,despite overwhelming evidence that Dr. Wood had committed scientific fraudas well as animal abuse.

BackgroundIn October 1993, based on internal documentation obtained from whistleblowers,In Defense of Animals (IDA) filed formal complaints with the U.S. Departmentof Agriculture (USDA) and the National Institutes of Health (NIH)'s Officefor Protection from Research Risk (OPRR) alleging inadequate veterinarycare and program-wide abuses at NYU during the conduct of Dr. Wood's experiments.Both agencies upheld IDA's allegations. In fact, the USDA filed formal chargesagainst NYU in April 1995 specifically regarding Dr. Wood's multiple violationsof federal law governing animal research. The USDA formally cited Dr. Wood'sfailure to provide adequate veterinary care to three monkeys who needlesslydied directly because of his veterinary and scientific negligence, and hisfailure to inform the NYUMC IACUC for over one year of his severe but unnecessary21 hours per day water deprivation. This past summer, NYU settled theseand other charges by agreeing to pay $450,000 -- by far the largest fineever assessed against a research institution for violations ofthe Animal Welfare Act. In addition, NIH OPRR found a veritable laundrylist of Public Health Service (PHS) Policy violations committed by NYUMCand Dr. Wood, including the violations that formed the basis of the formalUSDA charges.

Scientific fraud and violations of federal law by Dr. Wood

A. Use of Compromised "Animal Models"The record of the OPRR investigation of NYU Medical Center, as well as internalNYU documents obtained by IDA, clearly demonstrate that Dr. Wood re-usedin his crack experiments monkeys who had been previously used in his tolueneinhalation experiments. These monkeys suffered from liver and other seriousorgan damage sustained in the toluene experiments. No valid scientific datacould be collected from these animals. Furthermore, despite the fact thattoluene is well-known and documented to cause damage to the liver, centralnervous system, kidneys and heart, Dr. Wood failed to conduct even basichealth screening on these monkeys before using them in his crack experiments.

In attempting to explain this serious negligence, Dr. Wood cited the separationof veterinary responsibility from his own scientific activities. However,proper veterinary care is an integral part of any animal experiment. Thus,it is the responsibility of the investigator to ensure that adequate veterinarycare is provided to the animal subjects. This fact is even more importantin Dr. Wood's case, since he had personal knowledge of the animals' previousexposure to toluene and other drugs of abuse, having conducted the experimentshimself. Had Dr. Wood conducted even a cursory literature search, or readthe material safety data sheet on toluene, he would have seen that toluenecauses liver and brain damage. Such searches are standard procedure foranyone conducting research on animals. Indeed, how can any researcher conductexperiments on living animals without first investigating the physiologicaleffects of the drugs under study? The consequences of such dereliction toboth the integrity of the data as well as the welfare of the animals areclear.

To make matters worse, Dr. Wood appears to have engaged in deception tocover himself after three monkeys needlessly died under his care in January-February1993. When the NYUMC IACUC confronted Dr. Wood with the documented damageto the liver and brain caused by toluene, thus calling into question hisresearch design, animal care and overall protocol, Dr. Wood used a 1981citation to claim that toluene was not hepatotoxic. In doing so, Dr. Woodignored the overwhelming scientific evidence documenting the toxic effectsof toluene on the liver and other organs -- evidence available to any layperson who searches the literature. Even if Dr. Wood unknowingly overlookedthe wealth of scientific data about toluene toxicity (including the materialdata sheet), this does not bode well for his scientific integrity becauseit means that Dr. Wood was conducting toluene research on animals withoutadequately researching the biologic effect of the drug on the animals. TheNYUMC IACUC informed Dr. Wood that toluene was, in fact, hepatotoxic andinstructed him to correct his statement to the contrary.

In addition, because of his inability and/or unwillingness to conduct hisresearch according to accepted scientific standards, Dr. Wood never performedroutine blood chemistries on the monkeys, which should be a prerequisitefor any research into animals' responses to drugs, let alone drugs knownto cause serious organ damage. Such tests on the monkeys in Dr. Wood's labwould have revealed the animals' abnormal liver function results. Indeed,necropsies on these monkeys revealed liver damage consistent with toluenetoxicity that is cited in the medical literature in two of the three animals;the third animal's liver was inexplicably not examined at necropsy.

As a result of the three monkey deaths, the NYUMC IACUC forced Dr. Woodto perform routine blood chemistries on the surviving monkeys in his colony.Dr. Wood should have been conducting these tests from the beginning of hisexperiments. Preliminary results revealed that four of the seven animalsin his colony showed abnormal liver results; the IACUC mandated furthertests to see if the three others had sub-clinical damage. The IACUC alsopointed that not only anesthesia, but also the very drugs Dr. Wood was testing,are cleared by the liver, further calling into question the scientific validityof Dr. Wood's program. Yet even after the three monkeys' deaths, Dr. Woodproposed to perform blood chemistries on the surviving monkeys in his labonly twice a year, indicating that he chose to remain either ignorant orapathetic regarding the monkeys' liver function despite the needless deathsof three monkeys, and demonstrating once again why he should not be allowedto conduct any research on animals.

Moreover, toluene also causes brain damage, which Dr. Wood would have knownif he had consulted the literature or the material data sheet. At necropsy,Dr. Wood failed to ensure that the brains of the three monkeys were examined.This is a very serious oversight, given toluene's effect on the centralnervous system. However, since two of the three monkeys' livers showed damageat necropsy (as previously mentioned, the liver of the third was inexplicablynot examined), it is likely that the other major target organ of toluene-- the brain -- was also affected in these monkeys. As a psychologist, Dr.Wood should have been keenly interested in brain damage, particularly sincehe was supposed to be studying the behavioral effects of toluene and crackcocaine.

It is clear that Dr. Wood's failure to investigate or understand the damageto vital organs caused by exposure to toluene calls into serious questionany results from his experiments. Dr. Wood was studying crack inhalationon sick animals and, accordingly, his "results" were, at best,suspect, and could provide false and misleading information if applied tothe development of therapies for human drug addicts.

B. Severe Water Deprivation of Monkeys Also Compromises Wood's "Animal Model"Dr. Wood acknowledged that his water deprivation of monkeys -- for as longas 21 hours per day -- was serious enough to cause serum osmolarity changesin the animals. Incredibly, Dr. Wood stated that he was not concerned aboutthese changes, since serum osmolarity was not the focus of his research.Behavioral changes associated with crack inhalation were, however, a focusof his research. Since changes in serum osmolarity affect not only the healthand well-being of animals, but also their cognitive abilities, Dr. Woodshould have been very concerned about this variable. His failure to considerthe impact on his research results of water deprivation severe enough tocause serum osmolarity changes is a gross oversight and consistent withDr. Wood's slipshod approach to the conduct of research.

Dr. Wood also failed to inform the NYUMC IACUC for over one year of his21 hours per day water deprivation of the monkeys. When asked by the IACUCto provide literature citations for the 21 hours per day, he instead providedreferences for 18 hours per day deprivation, once again demonstrating hisinability and/or unwillingness to adhere to accepted scientific standardsand search the literature to justify his experimental protocol. Dr. Wood'ssevere water deprivation regimen came to the attention of the IACUC onlyafter a technician in Dr. Wood's lab wrote of her concern about the signsof extreme thirst in the animals. Moreover, Dr. Wood informed the IACUCthat he checked the patency of the animals' automatic water supply onlyif the animals stopped eating solid food (presumably because of excessivethirst). He was thus using the animals' solid food intake as the indicatorfor the functioning of the water supply! Only after the IACUC pointed outthe inadequacy of this "method" did Dr. Wood change his procedure.

C. False Statements to Funding AgencyIn his grant applications, Dr. Wood claimed to NIDA that he kept detaileddaily logs of the animals' behavior and health, and monitored them vigilantly.But a subcommittee appointed by NYU itself concluded that Dr. Wood's recordswere sparse, unclear and wholly inadequate, a finding supported by OPRR.Failure to keep adequate records is a transgression of accepted scientificstandards, and thus of good research.

Dr. Wood also failed to inform NIDA of changes in his research protocol,despite being repeatedly told to do so by the NYUMC IACUC. Moreover, Dr.Wood admitted that he had "deliberately" not given NIDA informationabout his experimental protocol, including his proposed use of other animalspecies, because to withhold such information was, in his opinion, "bettergrantsmanship."

A researcher who misrepresents the nature of his research to the fundingagency, and fails to adhere to the research protocol approved by the fundingagency should not in the future be entrusted with federal research grants.

D. Dr. Wood's Own Statements Belie Claims about the Value of his ResearchDr. Wood himself publicly acknowledged in 1991 in the Village Voice thatthe results of his research have never been used by clinicians, drug counselorsor federal agencies responsible for regulating workplace solvents. Woodjustified his work's lack of clinical worth by stating: "Value. Everyonealways asks about value, human applicability. Whatever happened to intellectualcuriosity, fascination, the excitement a scientist feels when he finds somethingnew?"

Furthermore, in a December 1993 letter to NYUMC IACUC chairman Dr. DanielRifkin requesting that the IACUC lift the suspension of his research, Dr.Wood revealed that personal financial gain and careerism overshadowed thepursuit of medical knowledge as motivations for his research activities."This project covers not just my salary, but also that of an associate....Thus,there are families at this table....Most importantly for us as professionalsis the reality that research careers are dependent on productivity. Thisis the period in which we must have peak productivity for us to have continuedacademic careers," he wrote. Despite Dr. Wood's reference to productivity,his research, in fact, has been singularly unproductive. As of September19, 1996 a search of Medline reveals no publications on his primate crack-smokingor toluene-inhalation experiments.

NIH decision to re-fund Dr. Wood's researchOn June 26, 1996, Catherine Sasek, Ph.D. of NIDA wrote the following toIDA:

"At this time NIDA is not providing funding to Dr. Ron Wood. Any grantthat Dr. Wood might submit to NIDA would receive a thorough and carefulreview. This grant would have to receive approval from the InstitutionalAnimal Care and Use Committee at Dr. Woods (sic) institution prior to submission.It would be carefully reviewed for the appropriate use of animals and thescientific merit of the proposed experiments by recognized experts in thefield. It would also be reviewed by staff at NIDA to ensure appropriateuse of animals. Finally, it would be reviewed by NIDA's Advisory Council."

On October 20, 1995, Dr. Louis Sibal of NIH's Office of Laboratory AnimalResearch had written to a concerned citizen:

"Dr. Wood's grant support from the National Institute on Drug Abuse (NIDA). . . ended in August [1995] . . . However, he has reapplied for funds tocontinue the project. Contrary to information that you may have receivedfrom other sources, two panels of scientists with expertise in related areasof research have judged Dr. Wood's project to be scientifically and technicallymeritorious . . . On the basis of these evaluations, it is highly likelythat NIDA will resume the funding of this project in the near future. .. " (Emphasis added)

IDA has written repeatedly to Dr. Sibal and to NIDA to clarify these seeminglycontradictory statements. To date, no response has been received. We alsowe asked Dr. Sibal if the peer reviewers reviewed the documentation aboutWood's misconduct, but he never provided a response. We posed the same questionto NIDA, but have not, to date, received a response from that agency. Inaddition, since the processing of a grant application usually takes months,it is apparent that NIDA was being less than forthcoming in its June 26,1996 public statement about Dr. Wood's funding status.

The fact that NIDA peer reviewers apparently recommended re-funding of Dr.Wood's research meritorious indicates a very serious problem. If the reviewerssaw the documented evidence of Dr. Wood's scientific and veterinary misconduct,and recommended refunding his research anyway, then it appears that thesepeer reviewers are not sufficiently objective as to render honest recommendationsabout the merit of scientific research proposals. If, on the other hand,the peer review team did not review the evidence, the peer review systemis failing because reviewers are making decisions based on grievously incompleteinformation. Whatever the answers, this situation does not bode well forthe integrity of the National Institute on Drug Abuse or the integrity ofthe peer review process. If the peer review team was aware of the documentationcited above and still deemed Dr. Wood's research "meritorious"of funding, then the peer review process is demonstrated to be incapableof providing objective assessments of worthy research projects. If the peerreview team made determinations about Dr. Wood's research in the absenceof the results of federal investigations into his research, then the NIHhas failed utterly to provide oversight to federally-funded animal researchas required by law.